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    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-001202-32
    Sponsor's Protocol Code Number:TA799-007
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-09-01
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2020-001202-32
    A.3Full title of the trial
    A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of apraglutide in adult subjects with short bowel syndrome and intestinal failure (SBS-IF)
    Estudio multicéntrico, con enmascaramiento doble, aleatorizado, comparativo con un placebo, para evaluar la eficacia y la seguridad de apraglutida en pacientes adultos con síndrome de intestino corto y fallo intestinal (SIC-FI)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of apraglutide in short bowel syndrome and intestinal failure
    Eficacia y seguridad de apraglutida en síndrome de intestino corto y fallo intestinal
    A.3.2Name or abbreviated title of the trial where available
    Efficacy and Safety of apraglutide in SBS-IF
    Eficacia y Seguridad de apraglutida en SIC-FI
    A.4.1Sponsor's protocol code numberTA799-007
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVectivBio AG
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportVectivBio AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVectivBio AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressAeschenvorstadt 36
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4051
    B.5.3.4CountrySwitzerland
    B.5.5Fax number+4144 660 6590
    B.5.6E-mailclinicaltrial.enquiries@vectivbio.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2102
    D.3 Description of the IMP
    D.3.1Product nameapraglutide
    D.3.2Product code TA799
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAPRAGLUTIDE
    D.3.9.1CAS number 1295353-98-8
    D.3.9.2Current sponsor codeTA799; FE 203799
    D.3.9.3Other descriptive nameapraglutide
    D.3.9.4EV Substance CodeSUB193006
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    short bowel syndrome and intestinal failure
    síndrome de intestino corto y fallo intestinal
    E.1.1.1Medical condition in easily understood language
    short gut
    intestino corto
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10049416
    E.1.2Term Short-bowel syndrome
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of weekly SC apraglutide in reducing parenteral support dependency
    Evaluar la eficacia de la administración semanal de apraglutida por vía s.c. desde el punto de vista de la reducción de la dependencia de NP
    E.2.2Secondary objectives of the trial
    To evaluate selected parameters indicative of clinical efficacy
    • To evaluate the safety and tolerability of apraglutide compared with placebo
    • To assess the PK of apraglutide
    Evaluar determinados parámetros indicativos de la eficacia clínica
    • Evaluar la seguridad y la tolerabilidad de apraglutida en comparación con el placebo
    • Evaluar la farmacocinética (FC) de apraglutida
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent for this trial prior to any trial specific assessment.
    2. Male and female subjects with SBS-IF, receiving parenteral support (PS), secondary to surgical resection of the small intestine with either stoma or colon-in-continuity (CIC).
    3. Subject must require PS at least 3 days per week and be considered stable.
    4. No restorative surgery intended to change PS requirements in the trial period.
    5. Age ≥18 years at screening.
    1. Haber firmado el consentimiento informado para este estudio antes de realizar ninguna de las evaluaciones específicas del estudio.
    2. Pacientes de ambos sexos con SIC-FI, que reciban nutrición parenteral (NP), derivado de la resección quirúrgica del intestino delgado que presenten estoma o colon en continuidad (CEC).
    3. Que el paciente precise NP al menos 3 días a la semana y se considere que es estable.
    4. No tener previsto someterse a una intervención de cirugía restauradora para modificar la demanda de NP durante el período del estudio.
    5. Edad ≥ 18 años en el momento de la selección.
    E.4Principal exclusion criteria
    1.Pregnancy or lactation.
    2.Major abdominal surgery in the last 6 months prior to screening.
    3.History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer.
    4.Evidence of active inflammatory GI conditions in the previous 6 months.
    5.Evidence of decompensated heart failure.
    6.Evidence of severe renal or hepatic impairment.
    7.Any previous use of growth factors such as growth hormone (GH), native GLP-2, GLP-1, or GLP-2 or GLP-1 analogues should be discussed with the Investigator.
    1. Mujeres embarazadas o en período de lactancia.
    2. Haberse sometido a una intervención de cirugía mayor abdominal en los 6 meses anteriores a la selección.
    3. Antecedentes de cáncer (incluido el carcinoma de colon) o de enfermedad linfoproliferativa clínicamente importante en el transcurso de ≤5 años, salvo los casos de cáncer cutáneo de células basales tratado adecuadamente.
    4. Evidencia de enfermedad inflamatoria intestinal activa en los 6 meses anteriores.
    5. Evidencia de insuficiencia cardíaca descompensada.
    6. Evidencia de función renal o hepática insuficiente.
    7. El uso anteriormente de factores de crecimiento (como la hormona del crecimiento [HC], GLP-2 o GLP-1 endógenos o análogos del GLP-2 o del GLP-1) deberá ser hablado con el investigador.
    E.5 End points
    E.5.1Primary end point(s)
    Relative change from baseline in actual weekly PS volume at Week 24.
    Variación relativa en la semana 24 respecto al período inicial en el volumen semanal real de NP.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 24
    semana 24
    E.5.2Secondary end point(s)
    •Subjects who achieve a reduction of at least 1 day per week of PS from baseline at Weeks 24 / 48.
    •Relative change from baseline in actual weekly PS volume at Weeks 12 / 24 / 48.
    •SBS-IF patients reaching enteral autonomy at Weeks 24 / 48.
    •At least 20% reduction of PS volume from baseline at Weeks 20 / 24.
    •Calorie reduction in the PN at Weeks 24.
    •Change from baseline on QoL measures at Weeks 24 / 48.
    •Apraglutide PK parameters (baseline through Week 48).
    • Pacientes que en la semana 24 / 48 alcancen una reducción de al menos 1 día a la semana en la NP respecto al período inicial.
    • Variación relativa en la semana 12 / 24 / 48 respecto al período inicial en el volumen semanal real de NP.
    • Pacientes SIC-FI que en la semana 24 / 48 alcancen la autonomía enteral.
    • Pacientes que presenten al menos un 20 % de reducción en el volumen de NP en las semanas 20 / 24 respecto al período inicial.
    • Reducción calórica en la NP en la semana 24
    • Variación entre el período inicial y la semana 24 / 48 en los resultados de los cuestionarios de calidad de vida.
    • Parámetros farmacocinéticos de apraglutida desde el período inicial hasta la semana 48.
    E.5.2.1Timepoint(s) of evaluation of this end point
    specified at point E.5.2
    especificado en el apartado E.5.2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    China
    Israel
    Japan
    Korea, Republic of
    Taiwan
    United States
    Belgium
    Denmark
    France
    Germany
    Italy
    Norway
    Poland
    Spain
    Sweden
    United Kingdom
    Czechia
    Argentina
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days16
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 144
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Continuous treatment in a Long-term Safety and Clinical Outcomes Extension Trial (LTE) may be offered to subjects at the final planned dosing visit in this trial, allowing subjects in the placebo arm to also have the option of receiving apraglutide. The open-label LTE trial will be described in a separate protocol.
    Podría ofrecerse a los pacientes continuidad del tratamiento en un ensayo a largo plazo de seguridad y resultados clínicos (LTE) al final de la última visita planeada en la que se administra el tratamiento en este ensayo, permitiendo a los sujetos del brazo del placebo tener también la opción de recibir apraglutida. El ensayo LTE abierto será descrito en un protocolo separado.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-02-22
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